Drugs Division

The Drugs Division contributes to the attainment of the functions of the Food and Drugs Board for safeguarding public health by ensuring that all medicines on the market meet appropriate standards of safety, efficacy, and quality by evaluating all information submitted in the registration dossiers, pre-registration inspection, and drug quality analysis reports. .

The Division also evaluates and registers veterinary medicines to promote and protect animal health and to ensure safe animal products for human consumption

The activities of the Drugs Division are carried out by three specialised departments and supported by seven operational Units.

Drug Evaluation and Registration Department

The Drug Evaluation and Registration Department is made up of the following operational Units:

Medicine and Vaccines Evaluation and Registration Unit

• This Unit registers medicine and vaccines and issues certificates for a period of three years after which re-registration is required.Product registration meetings are held on bi-monthly basis to review applications for product registration. Assessment of applications for the registration of medicine and vaccines products involves the following:
  
  
• Evaluation of dossiers submitted for registration to ensure that application forms are properly completed and the requisite information and certificates are duly submitted..
• Ensuring information provided on packages and package inserts are correct, adequate and conforms to the labelling requirements enforce in Ghana that will enable the Board take appropriate decisions.
• Conducting evaluation meetings for medicines and vaccines product approval.
• Registration of all veterinary medicines
• Active maintenance of SIAMED Database.
  
• Medicine Products advertisement approval .
  
• Vetting of scripts submitted for advertisement to ensure that the content is acceptable to the Board
• Evaluation of promotional materials
• Issuance of Import Permits
  

  The assessment of applications for import permit involves the following:

• Ensuring that products to be imported have valid registration numbers.
• Names of products and their respective quantities stated in invoices tally with information provided in application forms.
• Ensuring that application submitted is acceptable to the Board

Safety Monitoring Unit

• The main functions of the Unit are:
  
• To coordinate the activities of the Post-Market Surveillance Unit to monitor Adverse Drug Reactions (ADRs).
• Promotion of spontaneous reporting of Adverse Drug Reactions (ADRs) and Adverse events following immunisation in Ghana.
• Assessment and validation of completed ADR case report forms and onward submission to the WHO collaborating Centre for International Drug Monitoring known as Uppsala Monitoring Centre.
• Communication of drug-related problems and recommended regulatory actions to stakeholders.
• Pharmacoepidermiological studies/ and other research activities (through designated research centres).
• Maintaining contacts with international institutions working in Pharmacovigilance such as WHO Department of Essential Drugs and Medicines Policy (Geneva), and The Uppsala Monitoring Centre (Sweden).
• Serve as Product Information Centre.
• Collaborate with local stakeholders and professional associations

Herbal Medicine Unit

The main functions of the Herbal Medicine Units are:

• Registration, processing and evaluation of all herbal medicines applications.
• Evaluation of toxicological and clinical information as well as therapeutic data submitted from Centre for Scientific Research into Plant Medicine, Mampong-Akuapim, Noguchi Memorial Institute for Medical Research, Legon-Accra, Faculty of Pharmacy, KNUST-Kumasi, and Department of Pharmacology, Korle-Bu Teaching Hospital.
• Products that are recommended for registration are issued with registration number, which are valid for One (1) year in case of locally manufactured products and three years for imported herbal drugs.

Cosmetics, Household Chemicals and Medical Devices Unit

• The Unit's main functions are:
  
• Registration and evaluation of all documents for cosmetics, medical devices and household chemical substances.
• Developing and reviewing guidelines for the evaluation of cosmetics, medical devices and household chemicals.

Drug Inspectorate Department

The Department's main functions include the pre-licensing and post licensing inspections of pharmaceutical, herbal, cosmetic and household chemical manufacturing industries. The Department also conducts inspection of local and foreign drug manufacturing facilities to verify compliance to Good Manufacturing Practice (GMP).

The departments is made up of the following units:

Drug Premises Inspection Unit

• The Unit’s main functions are:
  
• Conducting routine GMP audit inspections of all the pharmaceutical manufacturing companies that are registered with the Board.
• Conducting routine GMP inspection in pharmaceutical, herbal, cosmetics and household chemical manufacturing companies.
• Conducting external Good manufacturing Audit inspections of pharmaceutical industries carrying out business in Ghana.

Drug Post-Market Surveillance Unit

• The Unit monitors drugs, cosmetics, medical devices and household chemicals for ensuring public health and safety and consumer confidence. The main functions of the Unit include:
  To collaborate with Pharmacy Council to continuously monitor quality of products on the Ghanaian market.
• Conduct operational research on products registered by the Board on the Ghanaian market.
• Monitor products on the Ghanaian market for registration, expiry date, and labelling conformance.
• Liaise with Port Offices to monitor medicines and other product donations.
• Reconcile inventory and perform destruction of expired products.
• Monitor and review drug promotion and advertising.
• Monitor storage facilities of clinics, hospitals, central medical stores and regional medical stores.
• Investigate issues on consumer complaints and counterfeiting.

Tobacco and Substances of Abuse Department

The principal function of the Department is to exercise regulatory control on the use of tobacco, narcotics and psychotropic substances.